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Coronary Artery DiseasePICCOLETO VNCT06551662

DCB vs. DES in Bifurcation Coronary Lesions

A study testing Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons and New generation drug-eluting stent in people with Coronary Artery Disease and DCB, run by Fondazione Ricerca e Innovazione Cardiovascolare ETS at 17 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is an investigator-driven prospective, multicentric, international, randomized clinical study, in an open-label randomized fashion, where patients with bifurcation coronary artery disease (Medina: 111,101,011,001) in vessels with diameter >2.0 (visual estimation) and with a clinical indication to PCI, will be… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease, DCB
What is being tested?
Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons and New generation drug-eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
321 participants
Where
17 sitesin 4 countries
Study dates
1 Aug 2025to 1 Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be age ≥18 years.
  • Subject has silent ischemia, or stable/unstable angina, or acute MI older than 1-week from the onset of chest pain to admission.
  • Subject understands the trial design and treatment procedures and provides written informal consent before entering the trial
  • Subject is willing to comply with all protocol-required follow-up evaluations.
  • Target lesion must be native non-LM bifurcation lesion
  • Target lesion must be a bifurcation lesion on coronary angiography (defined as Medina 0,1,1, Medina 1,0,1, Medina 1,1,1 or Medina 0,0,1 coronary bifurcation lesions) and is eligible for percutaneous coronary intervention (PCI).
Show all 10Show fewer
  • Target lesion reference vessel diameter (both main vessel and side branch)
  • 2.0 mm by visual estimation.
  • Target lesion must have visually estimated stenosis ≥50%.
  • Target lesion length of side branch must be <25 mm by visual estimation.

Who cannot join

  • Patient with STEMI (within 3 days from the onset of chest pain to coronarography).
  • Patient has known allergy to the study balloon/stent system.
  • Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.
  • Patient is pregnant or nursing.
  • Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure.
  • Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.
Show all 17Show fewer
  • In-stent restenosis lesion.
  • Chronic total occlusion (CTO) lesion in either main vessel or side branch.
  • Left ventricular ejection fraction <30%;
  • Visible and untreatable thrombus at lesion site;
  • Target lesion/vessel with any of the following characteristics:
  • Severe and/or >270° calcification of the target vessel, also proximal to the lesion (intravascular imaging);
  • Bifurcation lesion where stent strategy is anticipated;
  • Left main stem stenosis >50%;
  • Target lesion is in the left main stem;
  • Lesions length >50 mm (main vessel)
  • Lesions length >25 mm (side branch)

Trial locations and contacts

17 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Bernardo Cortese contact

504827636

bcortese@gmail.com

Wojciech Wańha contact

504827636

wojciech.wanha@gmail.com

17 sites in 4 countries

Poland13 sites, 13 recruiting

  • First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland

    Gdansk

    Maksymilian Mielczarek, Prof., max.mielczarek@gmail.com

    Miłosz Jaguszewski, Prof.

    Not yet recruiting

  • Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland

    Katowice, 40-635

    Wojciech Wańha, MD, PhD, 0048504827636, wojciech.wanha@gmail.com

    Wojciech Wańha, PhD

    Not yet recruiting

  • Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland

    Krakow

    Jacek Legutko, jacek.legutko@uj.edu.pl

    Jacek Legutko, Prof.

    Not yet recruiting

  • Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland

    Krakow

    Stanisław Bartuś, Prof., 12 400 22 50, mbbartus@gmail.com

    Stanisław Bartuś, Prof.

    Not yet recruiting

  • Department of Cardiology, Copper Health Centre (MCZ)

    Lubin

    Adrian Włodarczak, MD, PhD, wlodarczak.adrian@gmail.com

    Adrian Włodarczak, MD, PhD

    Not yet recruiting

  • Clinical Department of Interventional Cardiology, Medical University of Lublin

    Lublin

    Piotr Waciński, piotr.j.wacinski@gmail.com

    Not yet recruiting

  • Department of Cardiology, Poznan University of Medical Sciences

    Poznan

    Sylwia Iwańczyk, MD, PhD, syl.iwanczyk@gmail.com

    Sylwia Iwańczyk, MD, PhD

    Not yet recruiting

  • Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow

    Rzeszów

    Piotr Wańczura, MD, PhD, p.wanczura@poczta.fm

    Not yet recruiting

  • Department of Cardiology

    Wałbrzych

    Jacek Bezubka

    Not yet recruiting

  • Department of Cardiology and Internal Diseases, Military Institute of Medicine

    Warsaw

    Piotr Kwiatkowski, MD

    Not yet recruiting

  • Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration

    Warsaw

    Robert Gil, Prof., (22) 508 11 00, scorpirg@gmail.com

    Robert Gil, Prof.

    Not yet recruiting

  • Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University

    Wroclaw

    Wiktor Kuliczkowski, Prof., wkuliczkowski@wp.pl

    Wiktor Kuliczkowski, Prof.

    Not yet recruiting

  • Third Department of Cardiology, Medical University of Katowice

    Zabrze

    Mariusz Gąsior, Prof., 32 373 36 00, m.gasior@op.pl

    Mariusz Gąsior, Prof.

    Not yet recruiting

Other trials in Poland

Romania2 sites, 2 recruiting

  • Heart Institute, Cluj-Napoca

    Cluj-Napoca

    Alexandru Achim, MD, 0040753803716, dr.alex.achim@gmail.com

    Recruiting

  • Sibiu County Emergency Clinical Hospital

    Sibiu

    Leontin Lazar, MD, 0040747805999, lazar.leontin@yahoo.com

    Recruiting

Other trials in Romania

Italy1 site, 1 recruiting

  • Fondazione Ricerca e Innovazione Cardiovascolare

    Milan

    Bernardo Cortese

    Bernardo Cortese

    Not yet recruiting

Other trials in Italy

Singapore1 site, 1 recruiting

  • Tan Tock Seng Hospital

    Singapore

    Bharat Khialani, drbkhialani@gmail.com

    Not yet recruiting

Other trials in Singapore

About this study

Official title: Drug-coated Balloons vs. Drug Eluting Stents in Bifurcation Coronary Lesions: PICCOLETO V Study

This is an investigator-driven prospective, multicentric, international, randomized clinical study, in an open-label randomized fashion, where patients with bifurcation coronary artery disease (Medina: 111,101,011,001) in vessels with diameter >2.0 (visual estimation) and with a clinical indication to PCI, will be enrolled. After successful predilatation (with any tool deemed useful), patients will be randomized 1:1:1 to SCB, PCB or standard treatment with DES for bifurcation native vessel disease. All patients with a clinical indication for PCI, both stable coronary artery disease and acute coronary syndrome, will be enrolled.

Before participating all the candidates will be clearly informed about the study, including the possible risks and benefits, and will be asked to provide a written informed consent. Subjects will be instructed that may not meet the general criteria for inclusion or the angiographic criteria, or that may have at least one exclusion criteria, and then be excluded from the study (screening failure), even after informed consent is obtained.

Consecutive patients who meet at least one of the inclusion criteria and none of the exclusion criteria, will participate to the study. After randomization, the procedure will consist in standard coronary angioplasty following international guidelines/consensus documents and as per local practice. If the patient has been randomized to SCB or PCB, it is mandatory to adequately prepare the lesion.

Being tested
Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons, New generation drug-eluting stent
Keywords
Coronary artery disease, Bifurcation coronary lesions, Drug-coated balloons
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paclitaxel drug-coated balloonsDevice

    Patients will be randomized to Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons or standard therapy with new generation drug-eluting stent

  • Sirolimus drug-coated balloonsDevice

    Patients will be randomized to Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons or standard therapy with new generation drug-eluting stent

  • New generation drug-eluting stentDevice

    Patients will be randomized to Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons or standard therapy with new generation drug-eluting stent

Study groups in NCT06551662
Study groupRoleWhat they receive
Device: Paclitaxel drug-coated-balloonsExperimentalNot described
Receives: Device: Paclitaxel drug-coated balloons
Device: Sirolimus drug-coated-balloonsExperimentalNot described
Receives: Device: Sirolimus drug-coated balloons
Device: new generation drug-eluting-stentsActive comparatorNot described
Receives: Device: New generation drug-eluting stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-9 Month CT-FFR or Invasive FFR in Bifurcation Lesions

    6-9-month CT-scan FFR (core lab)

    • 6-9-month Main vessel CT-FFR
    • 6-9-month Side branch CT-FFR or

    If invasive coronary angiography indicated at 6-9 months:

    • invasive FFR of Main vessel
    • invasive FFR of Side branch

    Measured: 6-9-month

  2. 6-9-Month CT-FFR or Invasive FFR: % Max Stenosis (Main + Side Branch)

    6-9-month CT-scan FFR (core lab):

    • Main vessel % maximum stenosis
    • Side branch % maximum stenosis or

    If invasive coronary angiography indicated at 6-9 months:

    • Main vessel % maximum stenosis
    • Side branch % maximum stenosis

    Measured: 6-9-month

Secondary outcomes (9)

  1. MACE

    The MACE was defined as a composite of total mortality, TVR, and spontaneous TV-MI.

    Measured: 24 +/- 1 months

  2. Cardiac death

    Cardiac death rates at 24+/- 1 months follow-up

    Measured: 24+/- 1 months

  3. All-cause death

    All-cause death rates at 24+/- 1 months follow-up

    Measured: 24+/- 1 months

  4. Q-wave MI

    Q-wave MI rates at 24+/- 1 months follow-up

    Measured: 24+/- 1 months

  5. Any MI

    Any MI rates at 24+/- 1 months follow-up

    Measured: 24+/- 1 months

  6. TLR

    TLR rates at 24+/- 1 months follow-up

    Measured: 24+/- 1 months

  7. TVR

    TVR rates at 24+/- 1 months follow-up

    Measured: 24+/- 1 months

  8. Vessel thrombosis

    Vessel thrombosis rates at 24+/- 1 months follow-up

    Measured: 24+/- 1 months

  9. Bleedings following BARC classification

    Bleedings following BARC classification at 24+/- 1 months follow-up

    Measured: 24+/- 1 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2024
  2. Study start1 Aug 2025
  3. Primary completion1 Feb 2026 (estimated)
  4. Study completion1 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
321 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06551662
Sponsor's protocol ID
PICCOLETO V
Acronym
PICCOLETO V
Status last verified
Sep 2025
First submitted
30 Jul 2024
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons and New generation drug-eluting stent in people with Coronary Artery Disease and DCB, run by Fondazione Ricerca e Innovazione Cardiovascolare ETS at 17 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Poland, Romania, Italy, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bernardo Cortese (504827636, bcortese@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-9 Month CT-FFR or Invasive FFR in Bifurcation Lesions (time frame: 6-9-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06551662.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

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